Class I recall issued for digoxin product

Veterinarians who use the human drug Digitek (digoxin tablets, USP, all strengths) to treat their patients should be aware that a Class I recall has been issued because of the possibility the tablet strength may be doubled. The Food and Drug Administration warns that this increase in tablet active ingredient could result in life-threatening adverse drug reactions in some animals.

The FDA Center for Veterinary Medicine issued the warning and notification May 16 after the manufacturer initiated a nationwide recall April 25. Recalls are voluntary actions by the firm involved. The FDA declares a recall Class I if a product defect is likely to cause substantial injury or death to humans or animals. Class I is the most demanding and requires a more thorough accounting of all product distribution.

Actavis Totowa LLC, a U.S. manufacturing division of the international generic pharmaceutical company Actavis Group, initiated the recall. The products are distributed by Mylan Pharmaceuticals Inc. under a Bertek label and by UDL Laboratories Inc. under a UDL label.

Any adverse reactions or quality problems should be reported to the FDA MedWatch Program by phone at (800) FDA-1088; by fax at (800) FDA-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch Web site at www.fda.gov/medwatch.